Package leaflet: information for the patient

Normaclin
10 mg/g, gel
Clindamycinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Normaclin is and what it is used for
Important information before using Normaclin
How to use Normaclin
Possible side effects
How to store Normaclin
Contents of the pack and other information

1. What Normaclin is and what it is used for

Normaclin is a medicine in the form of a topical gel intended for the local treatment of acne vulgaris. It contains the active substance clindamycin phosphate, which, when applied to the skin, is converted into the antibacterial antibiotic clindamycin. Clindamycin acts against Propionibacterium acnes bacteria, which are involved in the development of acne vulgaris. Allantoin, an auxiliary substance contained in the medicine, soothes skin irritation.

2. Important information before using Normaclin

When not to use Normaclin

if the patient is allergic to clindamycin or any of the other ingredients of this medicine (listed in section 6);
if the patient is allergic to lincosamide antibiotics (lincomycin);
in children under 12 years of age.

Warnings and precautions
Before starting treatment with Normaclin, consult a doctor:

if the patient has previously had the following gastrointestinal disorders: enteritis, Crohn's disease, ulcerative colitis, or antibiotic-associated colitis;
if the patient has myasthenia (a disease characterized by excessive muscle weakness).

While using Normaclin, the following warnings should be observed:

Avoid contact of the medicine with eyes, mucous membranes, and broken skin. In case of contact, wash the affected areas thoroughly with cool water.

Clindamycin phosphate applied topically may be absorbed through the skin into the body, and therefore, in very rare cases, severe gastrointestinal disease, known as pseudomembranous colitis, may occur during treatment with Normaclin.
Children
Do not use this medicine in children under 12 years of age.
Normaclin and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Inform your doctor if the patient is using:

muscle relaxants;
lincomycin, erythromycin, or other macrolide antibiotics (medicines used to treat infections).

Normaclin should not be used simultaneously with the above-mentioned medicines.
When using another topical medicine, do not apply it at the same time.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
There are no data on the safety of using this medicine during pregnancy and breastfeeding.
The medicine may be used during pregnancy only if, in the opinion of the doctor, it is clearly necessary.
Breastfeeding should not be performed during treatment with this medicine.
Fertility
There is no data on the effect of clindamycin on fertility.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
Normaclin contains propylene glycol and methyl parahydroxybenzoate (E 218)
Propylene glycol
The medicine contains 100 mg of propylene glycol in each 1 gram of gel.
Propylene glycol may cause skin irritation.
Methyl parahydroxybenzoate (E 218)
The medicine contains 1 mg of methyl parahydroxybenzoate in each 1 gram of gel.
Methyl parahydroxybenzoate may cause allergic reactions (including delayed-type reactions).

3. How to use Normaclin

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
Method of administration
This medicine is intended for topical application to the skin.
Adults and adolescents over 12 years of age:
Apply the medicine pointwise or in a thin layer, or spray it onto the affected skin area, twice daily
(do not rub in). Wash hands thoroughly after using the medicine.
The duration of treatment is determined by the physician. Optimal treatment results are achieved
after 8–12 weeks of use.
Children
Do not use this medicine in children under 12 years of age.
Instructions for use of the polyethylene bottle with spray pump
At first use, remove the cap, then point the spray nozzle in a safe direction and press the pump
several times until the first spray is released.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Use of a larger than recommended dose of Normaclin
If more than the recommended amount of medicine is used, contact your doctor immediately.
When applied topically, the medicine may be absorbed in amounts sufficient to cause systemic
adverse reactions of clindamycin (see section 4. Possible side effects).
Missed dose of Normaclin
Continue using the medicine as prescribed, without increasing the next dose.
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody will experience them.
Possible adverse reactions include:

excessive skin dryness, burning sensation, itching, redness, contact dermatitis, seborrhoea, folliculitis, allergic reactions (including delayed-type reactions), skin irritation, eye-area skin irritation;
gastrointestinal disorders (e.g. diarrhoea, abdominal pain, bloating, indigestion).

Clindamycin phosphate applied topically may be absorbed through the skin into the systemic circulation. Therefore, in very rare cases during treatment with Normaclin, severe pseudomembranous colitis may occur, with symptoms such as diarrhoea, including persistent, severe diarrhoea with mucus and blood, abdominal cramps, and colitis. The likelihood of such adverse reactions occurring with topical clindamycin-containing medicinal products is low.
If diarrhoea develops, treatment with Normaclin should be stopped immediately and medical advice should be sought to determine the cause and initiate appropriate treatment.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Normaclin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, tube, and carton. The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Normaclin contains

The active substance is clindamycin in the form of clindamycin phosphate. 1 g of gel contains 10 mg of clindamycin as clindamycin phosphate.
The other ingredients are: carbomer, allantoin, propylene glycol, macrogol 400, methyl 4-hydroxybenzoate (E 218), sodium hydroxide, purified water.

What Normaclin looks like and contents of the pack
Normaclin is a gel.
The pack consists of: tubes containing 15 g or 30 g of gel, or a high-density polyethylene (HDPE) bottle with a spray pump and cap (made of polypropylene, silicone, low-density polyethylene (LDPE), and stainless steel) containing 15 g or 30 g of gel, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100